global clinical trial solutions. real-world results. synta pharmaceuticals protocol 9090-08 the...

Global clinical trial solutions. Real-world results.

Synta PharmaceuticalsProtocol 9090-08The GALAXY Study

Investigator Meeting

BioClinica, Inc.


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Agenda

Imaging Objectives

Start-Up Procedures

Imaging Data Procedures at Sites

Imaging Data Procedures at BioClinica

BioClinica Responsibilities

Site Responsibilities

Imaging FAQs and Challenges


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Imaging Objectives

• High Quality

• Adherence to Imaging Guidelines

• Consistency in Data Acquisition

• Completed and Signed Data Transmittal Forms

• Submittal of Data within 5 Business Days

• Proactivity in Notifying BioClinica of Imaging Issues/Delays


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Start Up Procedures: Site Surveys and Study Kits

• Site Surveys» Purpose

– establishing communication

– identifying contact information for operative site personnel

– reviewing imaging equipment, and software archival capabilities

– identifying site-preferred media

» Completed by Study Coordinator or Other Site Designee

» 3 Site Survey Follow Ups


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Start Up Procedures: Site Surveys and Study Kits

• Study Kits» BioClinica Team Contact Information» Imaging Binder for Storage of Study-Related Forms

and Documents» Imaging and Submission Guidelines» General Principles for Submitting Film Data» Frequently Asked Questions (FAQs)» Quick Reference Guides (QRG)» Digital Archival Media (Pre-Labeled)» Film Labels» Black Paint Pens» Data Transmittal Forms» Sample Forms» Pre-Addressed Courier Air Waybills» Re-Order Supply Form» Mailer Envelopes


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Standardization and Consistency

• Data Acquisition (Across sites and Timepoints)» Equipment

» Parameters

» Slice Thickness

» Ensures consistency in the evaluation of study endpoints


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Imaging

•Whole Body Bone Scan, Screening, Q12 Weeks for Subjects with Bony Lesion at Screening, and/or where Clinically Indicated)

•Contrast Enhanced CT is the Preferred Modality

» Chest

» Upper Abdomen

•MRI is the Preferred Modality for the Brain (at Screening and at Follow Up time points as clinically

•PET/CT scanners may be used to acquire the above required CT scans if of diagnostic quality, but fused PET/CT images are not acceptable

•Non-Contrast CT of Chest and MRI of the Brain and Abdomen is recommended for Subjects with Contraindication to IV Contrast

•PET (must be performed prior to CT with IV contrast)


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PET/CT

• Some PET scanners can be used to acquire a CT scan• Fused CT/PET scans are not acceptable

» BioClinica cannot separate a fused CT/PET scan

• A CT acquired with a PET scanner is acceptable. To obtain optimal quality comparable to diagnostic CT, please adhere to the following:

» Oral and IV contrast

» Slice thickness of 3-5 mm preferred

» Patient positioning

• Consistency across timepoints for a subject is key» Same machine should be used

» Anatomy should be consistent


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CT Anatomic Coverage

• Brain (Baseline and as clinically indicated)» Cranial Vertex through Occiput

• Chest and Abdomen» Above lung apices to below illiac crest (to include liver)


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MRI Anatomical Coverage

• MRI of Brain (Screening and as Clinically Indicated)» Foremen magnum through vertex of skull

• MRI of Abdomen» Above diaphragm through liver to iliac crest

• Non-contrast CT of Chest» Diaphragm through liver to iliac crest


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• Image Data to BioClinica Within 5 Working Days

» Quick Image Submission Permits the Detection and Correction of

Problems Early On

• Digital Data is Preferred

» WebSend

» DICOM

• Film Data is Acceptable

» Complete Set of Films

» All Data Should Be Clean – No Marking

» Data Transmittal Forms

Image Submission Procedure


WebSend

• Web-based solution for expediting the sharing, tracking, archiving and analysis of medical images for multi-center clinical trials with imaging endpoints

• Protects patient confidentiality by automatically masking PHI

• Quick and easy implementation

• Automates the image tracking process

• Provides complete audit trail with time & date stamps

• Sites receive email confirmation of image receipt

• All image data is electronically backed-up and secure

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• Must be Completed for Each Patient/Timepoint• Site Retains Copy in Imaging Binder• Submit Original with Image(s)• Provides BioClinica with Information Vital to QC and Tracking of

Data» Site & Patient Identification

» Imaging Time Point

» Technical Information

» Imaging Parameters

» The identifiers (CRF number and exam date) on the DTF and CD labels must match the scan date imbedded in the data – NOT the study visit date. If you are unsure of the technical information required for the DTF, please ask your radiology department for assistance at the time they perform the imaging.

Data Transmittal Form


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CD and Film Labels

• CD Labels

» Pre-Printed with Synta Protocol Number and BioClinica Assigned Project Code

» Sites Complete Fields for:– Site Number/PI Name– Patient number/Initials– Imaging time point– Date of scan

• Film Labels» Labels must be affixed to each film submitted.


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Courier Waybills

• Pre-Printed • Pre-Addressed with BioClinica as Recipient • Contains a Unique Project Code (used by

BioClinica) • Only Sender Information Needs to be

Completed by the Site


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Data Quality Analysis/Quality Control

• Data Collection» Data Log-In/Tracking» DTF against Data» Translation/Digitization

• Review Process» Technical Adequacy» Protocol Compliance» DCF if needed» BioClinica will provide

confirmation of image quality for screening scabs prior to randomization of subjects


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Communication Methods to Sites

• Data Clarification Forms» Quality Issues, Missing Anatomy, Unacceptable Formatting, etc.» Require a Response (5 Business Days)

• Quality Notification Forms» Do Not Require a Response

• Site Data Summary Reports» Outstanding Scans» Outstanding Data Clarification Forms» Outstanding Surveys» Upcoming Scans


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Data Clarification Forms

• Generated by BioClinica

• Requires a Site Response

• Must Be Returned Within 1 Week

• Reasons for DCF(s)» Discrepancies» Missing Anatomy» Missing DTF(s)» Quality Issues


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BioClinica Responsibilities

• Provide Site Survey

• Provide Imaging Kit

• Collect Image Data

• Quality Control

• Follow-Ups on Outstanding Surveys and Data

• Address Site Requests and Concerns


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Site Responsibilities

• Site Survey Completion

• Alert Site Personnel to Imaging Requirements

• Acquire Protocol-Compliant Imaging

• Proper Labeling of Imaging and Films

• Completion of Data Transmittal Films

• Submittal of Data within 5 Business Days

• Prompt Response to Data Clarification Forms


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Frequently Asked Questions (1 of 2)

• Q: Whom should I contact if I have questions about acquiring data per Protocol?

» A: Your 1st line of contact should be the BioClinica Project Manager. Alternately, the Help Desk is available 24/7.

• Q: How Can I Acquire More Supplies » A: Complete and fax a supply order form, email the supplies contact, or

contact the Project Manager

• Q: Our site has already been contacted by BioClinica about Outstanding Survey information. Why have we been contacted again?

» A: BioClinica will follow up with sites 3 times for outstanding Surveys.


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Frequently Asked Questions (2 of 2)

• Q: Why is it necessary to acquire all images at 5mm?» Acquiring images at thicker slices could cause the independent

radiologists to miss critical anatomy.

• Q: In which format should data be submitted?» A: All data should be submitted in uncompressed DICOM data.

• Q: Our site would like data returned. Is this a problem?» A: Film data will be returned following digitization at BioClinica.

Copies of digital data should be submitted to BioClinica, to be returned at the study’s end. Should original data be submitted to BioClinica before a copy is made at the site, please contact the Project Manager. BioClinica will make a copy and return the original data.

• Q: Why is it necessary to inform BioClinica of scheduled scans that have not been performed?

» A: Un-Acquired scans will need to be removed from any reports/ follow ups detailing Outstanding Data.


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Contact Information

Cristen Kelleher

Project Manager

[email protected]

Tel: 267.757.3178

Fax: 267.757.1384

BioClinica [email protected]: 267.757.3002Fax: 267.757.1380

HelpDeskToll-Free (US and Canada):1-888-ASK-BIO2 (1-888-275-2462)Email: [email protected]